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Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life

Primary Purpose

Breast Cancer, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
BCSMS App
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, m-Health application, self-management, life of quality

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • first diagnosis of breast cancer with stage 0 to III in past year.
  • aged 20 to 65 years
  • had an Android/iOS smartphone;
  • able to read and write in Chinese;
  • willing to participate in the study and provide informed consent.

Exclusion Criteria:

  • not matched to inclusion criteria
  • mental illness
  • serious illness and life-threatening

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Experimental group with BCSMS App using

Control group without BCSMS App using

Outcomes

Primary Outcome Measures

Baseline EORTC QLQ-C30
Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Change of EORTC QLQ-C30 at 1.5 month
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3) to 1.5 month.The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Change of EORTC QLQ-C30 at 3 month
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3) to the 3rd month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.

Secondary Outcome Measures

Baseline EORTC QLQ-BR23
Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Breast 23 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Change of EORTC QLQ-BR23 at 1.5 month
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Breast 23 (version 3) to 1.5 month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Change of EORTC QLQ-BR23 at 3 month
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Breast 23 (version 3) to the 3rd month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.

Full Information

First Posted
November 19, 2019
Last Updated
November 20, 2019
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04174248
Brief Title
Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life
Official Title
The Evaluation of Intelligence Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life for Newly Diagnosed Non-metastatic Breast Cancer Women: Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
July 6, 2019 (Actual)
Study Completion Date
July 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study was to investigate the quality of life (QoL) for women with breast cancer in Taiwan after using the BCSMS App.
Detailed Description
After receiving their first diagnosis of breast cancer, women with stage 0 to III were randomized into intervention and control groups. Intervention group subjects used BCSMS App and the control group subjects received usual care. Two questionnaires: EORTC QLQ-C30 and EORTC QLQ-BR 23 were distributed to subjects in both arms at baseline and at 1.5 and 3 months. All evaluations were anonymous.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Quality of Life
Keywords
breast cancer, m-Health application, self-management, life of quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group with BCSMS App using
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group without BCSMS App using
Intervention Type
Other
Intervention Name(s)
BCSMS App
Intervention Description
Breast Cancer Using a Self-Management Support mHealth Application
Primary Outcome Measure Information:
Title
Baseline EORTC QLQ-C30
Description
Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Time Frame
Baseline
Title
Change of EORTC QLQ-C30 at 1.5 month
Description
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3) to 1.5 month.The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Time Frame
1.5 month
Title
Change of EORTC QLQ-C30 at 3 month
Description
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3) to the 3rd month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Time Frame
the 3rd month
Secondary Outcome Measure Information:
Title
Baseline EORTC QLQ-BR23
Description
Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Breast 23 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Time Frame
Baseline
Title
Change of EORTC QLQ-BR23 at 1.5 month
Description
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Breast 23 (version 3) to 1.5 month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Time Frame
1.5 month
Title
Change of EORTC QLQ-BR23 at 3 month
Description
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Breast 23 (version 3) to the 3rd month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Time Frame
the 3rd month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first diagnosis of breast cancer with stage 0 to III in past year. aged 20 to 65 years had an Android/iOS smartphone; able to read and write in Chinese; willing to participate in the study and provide informed consent. Exclusion Criteria: not matched to inclusion criteria mental illness serious illness and life-threatening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICing Hou, PhD
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
11221
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32130181
Citation
Hou IC, Lin HY, Shen SH, Chang KJ, Tai HC, Tsai AJ, Dykes PC. Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 4;8(3):e17084. doi: 10.2196/17084.
Results Reference
derived

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Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life

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